Method of treating diseased valve

ABSTRACT

A device and method for improving flow through a native blood vessel valve, such as the aortic valve, are provided. The present invention allows a miniature valve to be implanted into affected leaflets percutaneously, obviating the need for coronary bypass surgery. The method includes the cutting of small holes, on the order of 4 mm, in the leaflets of a targeted valve, thereby allowing blood to flow through the newly formed holes. The holes are used as attachment sites for the miniature valves of the present invention.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This invention is related to the invention described in theprovisional application serial No. 60/407,414 filed on Aug. 28, 2002entitled, MINI-VALVE HEART VALVE REPLACEMENT, and claims prioritytherefrom.

BACKGROUND OF THE INVENTION

[0002] Blood vessel valves include flexible tissue leaflets thatpassively alternate between open and closed positions as the forces of ablood stream act upon them. As blood flows in a first direction, theleaflets are urged apart from each other, and allow the blood to pass.Between pulses, as the blood attempts to flow in a reverse direction,the blood acts upon upstream surfaces of the individual leaflets,causing the leaflets to move inwardly. As the leaflets move inwardly,the edges of the individual leaflets (two, in the case of bicuspidvalves, and three in the case of tricuspid valves) abut against eachother, effectively blocking the blood flow in the reverse direction.

[0003] Valves are also present within the heart. The heart contains fourone-way valves that direct blood flow through the heart and into thearteries. Three of these valves, the aortic valve, the tricuspid valve,and the pulmonary valve, each have three leaflets. The fourth valve, themitral valve, has two leaflets. By defining a direction in which bloodcan flow, these valves are responsible for the resulting pump effect aheart has on blood when the heart beats.

[0004] A number of diseases result in a thickening, and subsequentimmobility or reduced mobility, of valve leaflets. Valve immobilityleads to a narrowing, or stenosis, of the passageway through the valve.The increased resistance to blood flow that a stenosed valve presentseventually leads to heart failure and death.

[0005] Treating severe valve stenosis or regurgitation has heretoforeinvolved complete removal of the existing native valve followed by theimplantation of a prosthetic valve. Naturally, this is a heavilyinvasive procedure and inflicts great trauma on the body leading usuallyto great discomfort and considerable recovery time. It is also asophisticated procedure that requires great expertise and talent toperform.

[0006] Historically, such valve replacement surgery has been performedusing traditional open-heart surgery where the chest is opened, theheart stopped, the patient placed on cardiopulmonary bypass, the nativevalve excised and the replacement valve attached. More recently, it hasbeen proposed to perform valve replacement surgery percutaneously, thatis, through a catheter, so as to avoid opening the chest.

[0007] One such percutaneous valve replacement method is disclosed inU.S. Pat. No. 6,168,614 (the entire contents of which are herebyincorporated by reference) issued to Andersen et al. In this patent, theprosthetic valve is collapsed to a size that fits within a catheter. Thecatheter is then inserted into the patient's vasculature and moved so asto position the collapsed valve at the location of the native valve. Adeployment mechanism is activated that expands the replacement valveagainst the walls of the body lumen. The expansion force pushes theleaflets of the existing native valve against the lumen wall thusessentially “excising” the native valve for all intents and purposes.The expanded structure, which includes a scaffold configured to have avalve shape with valve leaflet supports, is then released from thecatheter and begins to take on the function of the native valve. As aresult, a full valve replacement has been achieved but at asignificantly reduced physical impact to the patient.

[0008] One particular drawback with the percutaneous approach disclosedin the Andersen '614 Patent is the difficulty in preventing leakagearound the perimeter of the new valve after implantation. Since thetissue of the native valve remains within the lumen, there is a stronglikelihood that the commissural junctions and fusion points of the valvetissue (as pushed against the lumen wall) will make sealing of theprosthetic valve around the interface between the lumen and theprosthetic valve difficult. Furthermore, in some patients, thedeflection of the leaflets against the lumen walls could potentiallyobstruct the ostial openings of the lumen.

[0009] Although both the traditional open heart valve replacementsurgery and the newer percutaneous valve replacement surgery replace anative valve in entirely different ways and both have their drawbacks,the paradigm of these two approaches is identical: Render the nativevalve useless, either through excision (open heart) or immobilization(percutaneous), and then implant a completely new replacement prostheticvalve to take over. In other words, both approaches rely entirely on thepremise that the native valve must be entirely replaced (physically orfunctionally) by an entirely new prosthetic valve.

[0010] In contravention of the prior art, the present inventionintroduces an entirely different paradigm to valve replacement surgery,something neither taught nor contemplated by the open heart approach orthe percutaneous approach (e.g., U.S. Pat. No. 6,168,614) and somethingthat largely avoids the drawbacks associated with both. Morespecifically, the present invention is premised on leaving the nativevalve in place, not on its excision or immobilization, and thenutilizing the native valve as a platform for actually treating thediseased valve. This is a wholly new approach to treating diseasedvalves.

[0011] For example, in one embodiment of the invention, the physiciandiagnoses that the patient has a stenotic valve and then percutaneouslymounts a plurality of small “leaflet valves” or “mini-valves” on one ormore of the diseased native valve leaflets. In other words the nativevalve and its leaflets are used as a planar surface or a type of“bulkhead” on which new mini leaflet valves are mounted. The nativevalve remains in place but valve disfunction is remedied due to thepresence of these new leaflet valves. As a result, the diseased valve issuccessfully treated without the complication associated with removingthe native valve.

[0012] This leads to a much simpler and safer approach as compared tothe prior art. It avoids the invasive nature of the open heart approachand avoids the sealing and ostial blockage problems of the percutaneousapproach.

BRIEF SUMMARY OF THE INVENTION

[0013] The present invention relates to the treating of narrowed, stiffor calcified heart valves. The aforementioned problems with presenttreatment methods are addressed by treating the targeted valve leafletsindividually, rather than replacing the entire valve using an open-heartor a percutaneous procedure. That is, in the present method, the rigidheart valve leaflet is treated by introducing small prosthetic valvesinto the leaflet itself.

[0014] The present invention includes a method of treating theindividual leaflets of a targeted heart valve that includes installingone or more small, one-way valves into the targeted leaflets. Thesesmaller valves can be placed in the leaflet using catheter systems,obviating the need for opening the heart or great vessels,cardiopulmonary bypass, excision of the diseased valve, and athoracotomy. Additionally, multiple small valve placements might reducethe long-term risks associated with a complete prosthetic valve, becausefailure of an individual valve will not necessarily lead to cardiacfailure. The remaining small valves and remaining healthy native valvesmight be sufficient to sustain life.

[0015] One aspect of the present invention provides a method of placingsmall valves through a target valve that involves puncturing the targetvalve and pushing the miniature valve through the target valve tissue.The valve is then anchored in place using a variety of mechanismsincluding tabs, riveting of the valve housing, spines, frictionplacement or the use of a fixation cuff.

[0016] Another aspect of the present invention provides a variety ofvalve implant mechanisms constructed and arranged for placement in atarget valve leaflet. The valve implant mechanisms include a valvehousing that operably houses a valve mechanism such as a duckbill valve,a tilting check valve, a ball and cage valve, or a hinged leaflet valveor a valve using tissue leaflets. The valve implant may also include ananchoring mechanism such as tabs, spines, threads, shoulders, or adeformable housing.

[0017] The present invention also provides a device useable to remove asection of the target valve, without damaging the surrounding valvetissue, and inserting a valve implant into the void left in the targetvalve. The device is contained within a catheter such that a valveimplant insertion procedure can be accomplished percutaneously.Preferably, this delivery system is constructed and arranged to beplaced through a 14 French catheter, traverse the aorta, land on atargeted leaflet such as one of the leaflets of the aortic valve,puncture the leaflet at a predetermined spot, cut a hole on the order of4 mm in diameter, capture and remove any cut tissue, place a radiallycompressed one-way valve including a Nitonol attachment cuff and astainless steel sizing ring into the leaflet hole, securely attach thevalve assembly to the leaflet, dilate the hole and the valve assembly toa precise final diameter, such as 8 mm, using a balloon, and beretracted leaving the valve assembly in place in the leaflet.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018]FIG. 1 is a perspective view of three valve implants of thepresent invention installed in the leaflets of a tricuspid valve;

[0019]FIG. 2 is a side elevation of two valve implants of the presentinvention installed in a stenotic leaflet;

[0020]FIGS. 3a-f are side elevations of various embodiments of the valveimplant of the present invention;

[0021]FIG. 4a is a detailed sectional view of a preferred embodiment ofthe valve implant of the present invention in a compressed or foldedstate;

[0022]FIG. 4b is a detailed sectional view of the valve implant of FIG.4a in an expanded state;

[0023]FIGS. 4c-f are sectional views of alternative configurations ofthe preferred valve implant of the present invention;

[0024]FIG. 5a is a sectional view of an embodiment of the deliverysystem of the present invention;

[0025]FIG. 5b is a detailed sectional view of the distal end of thedelivery system of FIG. 5a;

[0026]FIG. 6 is a sectional view of the leaflet capture catheter of thepresent invention;

[0027]FIG. 7a is a sectional view of the delivery catheter of thepresent invention;

[0028]FIG. 7b is a perspective view of an alternative cutter of thepresent invention;

[0029]FIG. 8 is a sectional view of the sheath catheter of the presentinvention;

[0030]FIG. 9a is a detailed sectional view of the handle of the deliverysystem of the present invention;

[0031]FIG. 9b is a side elevation of the handle of FIG. 9a;

[0032]FIG. 10a is a side elevation of the handle of the presentinvention in a “Deliver” position;

[0033]FIG. 10b is a sectional view of the distal end of the deliverysystem of the present invention when the handle is in the “Deliver”position of FIG. 10a;

[0034]FIG. 11a is a side elevation of the handle of the presentinvention in an “Insert” position;

[0035]FIG. 11b is a sectional view of the distal end of the deliverysystem of the present invention when the handle is in the “Insert”position of FIG. 11a;

[0036]FIG. 12a is a side elevation of the handle of the presentinvention in a “Cut” position;

[0037]FIG. 12b is a sectional view of the distal end of the deliverysystem of the present invention when the handle is in the “Cut” positionof FIG. 12a;

[0038]FIGS. 13a-e are an operational sequence of the capture device ofFIG. 6 interacting with the cutting drum of FIG. 7a to remove andcapture a section of tissue from a target valve leaflet;

[0039]FIG. 14a is a side elevation of the handle of the presentinvention in a “Distal” position;

[0040]FIG. 14b is a sectional view of the distal end of the deliverysystem of the present invention when the handle is in the “Distal”position of FIG. 14a;

[0041]FIG. 15a is a side elevation of the handle of the presentinvention in a “Proximal” position;

[0042]FIG. 15b is a sectional view of the distal end of the deliverysystem of the present invention when the handle is in the “Proximal”position of FIG. 15a;

[0043]FIG. 16a is a side elevation of the handle of the presentinvention in an “Inflate” position;

[0044]FIG. 16b is a sectional view of the distal end of the deliverysystem of the present invention when the handle is in the “Inflate”position of FIG. 16a and a balloon of the delivery system is inflated;

[0045]FIG. 17a is a side elevation of the handle of the presentinvention in an “Inflate” position during a deflating procedure;

[0046]FIG. 17b is a sectional view of the distal end of the deliverysystem of the present invention when the handle is in the “Inflate”position of FIG. 17a and the balloon of the delivery system has beendeflated;

[0047]FIG. 18 is a sectional view of a valve implant of the presentinvention in a deployed configuration;

[0048]FIGS. 19A and 19B are cross-sectional views of a valve implant ofthe present invention in a deployed configuration;

[0049]FIG. 20 is a cross-sectional view of a portion of a catheterdelivery system in accordance with a preferred embodiment of the presentinvention;

[0050]FIG. 21 is a flow chart figure showing a tether retraction systemfor use in a catheter delivery system in accordance with the presentinvention;

[0051]FIGS. 22A and 22B are top views of a hinged valve in accordancewith another preferred embodiment of the present invention;

[0052]FIGS. 23A, 23B and 23C are cross-sectional views of a hinged valvein accordance with the present invention; and,

[0053]FIGS. 24A and 24B are cross-sectional views of a hinged valve inaccordance with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0054] Referring now to the Figures, and first to FIG. 1, there is showna native tricuspid valve 5 with a valve implant 10 of the presentinvention installed in each of the three leaflets 7 of the tricuspidvalve 5. The valve implants 10 are shown in an open position todemonstrate that blood is allowed to flow through the valve implants 10,in one direction, even though the native tricuspid valve 5 remainsclosed. These valve implants 10 would similarly work with a nativebicuspid valve, unicuspid valve or quadracuspid valve.

[0055]FIG. 2 demonstrates the positioning of a valve implant 10 in anative leaflet 7. The leaflet 7 is shown as having calcified tissue 9,characteristic of a stenosed valve. Notably, the valve implants 10 havebeen inserted through the calcified tissue 7. Also notable is that theremay be more than one valve implant 10 inserted into a single leaflet 7if additional flow capacity is desired. Alternatively, though not shown,the valve implant 10 may be installed between the leaflets 7. Thisconfiguration is especially feasible in heavily stenosed valves thathave relatively immovable leaflets. Such leaflets may be fully orpartially fused together. The valve implants generally comprise ananchoring mechanism 12 and a valve mechanism 14.

[0056] FIGS. 3-5 illustrate several embodiments of the valve implants 10of the present invention. In FIGS. 3a-f, a family of valve implants 10is provided that are characterized by a rigid housing 16 with aself-tapping tip 18. The valve implants 10 of FIGS. 3a-f include avariety of valve mechanisms 14 and anchoring mechanisms 12.

[0057] The valve implant 10 of FIG. 3a, as well as those of FIGS. 3c and3 d, has a valve mechanism 14 that comprises a single flap 20, hinged onone side, that acts against the rigid housing 16 to prevent flow in areverse direction. A benefit of this valve design is ease ofconstruction. The valve implant 10 of FIG. 3a also uses the frictionbetween the rigid housing 16 and the native heart leaflet 7 (FIG. 2) asan anchoring mechanism to hold the valve implant 10 in place. Thepointed tip 18 allows the valve implant 10 to be urged through, ortwisted through, the native heart leaflet without the need for cutting ahole in the leaflet prior to installing the valve implant 10. Thus, incertain cases, there is sufficient gripping power between the housing 16and the leaflet 7 to hold the housing 16 in place. This holding powermay be increased by providing a textured surface (not shown) on thehousing 16, or selecting a housing material, such as a mesh or stifffabric, that allows a controlled amount of ingrowth, sufficient tosecure the valve implant 10, but not so much as to cause a flowhindrance within the valve implant 10.

[0058] The valve implant 10 of FIG. 3b has a valve mechanism 14 thatcomprises a pair of members constructed and arranged to form a duckbillvalve 22. The duckbill valve 22 operates in a similar way to a tricuspidor bicuspid valve. When fluid flows through the valve in a desireddirection, each of the members of the duckbill valve 22 move apart fromeach other. When the flow reverses, such as during diastole, the fluidforces the members of the duckbill valve 22 together, closing the valve10.

[0059] Also included in the valve implant 10 of FIG. 3b is an anchoringmechanism 12. The anchoring mechanism 12 generally comprises a pluralityof radially extending posts 24. These posts 24 act against an upstreamside 26 (FIG. 2) of the leaflet 7, thereby counteracting systolicpressure from the blood stream.

[0060] The valve implant 10 of FIG. 3c includes a single flap 20 valvemechanism 14 and an anchoring mechanism 12 that includes a plurality ofangled barbs 28. The barbs 28 are located near the upstream side of thevalve implant 10 and are angled back toward the downstream side. Theangled barbs 28 may provide increased gripping power, especially if morethan one row, such as shown in FIG. 3c, are provided. Because one ormore of the rows of barbs 28 will be located within the leaflet 7 whenthe valve implant is in place, the barbs 28 provide resistance tomovement in both directions, and may stimulate ingrowth.

[0061] The valve implant 10 of FIG. 3d provides a combination of many ofthe features already discussed. The valve 10 has an anchoring mechanism12 that includes both posts 24, on the downstream side to prevent valvemovement in the upstream direction, and angled barbs 28 on the upstreamside of the valve 10. The valve mechanism 14 demonstrates another valvedesign. The valve mechanism is an outside-hinged dual flap valve 30. Theindividual flap members rotate about their outer edges when influencedby fluid flow.

[0062]FIG. 3e shows a valve implant 10 with a valve mechanism 14 thatuses an inside-hinged dual flap valve 32, with individual flap membersthat rotate about their inner edges when influenced by fluid flow. Thevalve implant 10 combines upstream posts 24 with upstream-angled barbs28 on the downstream side of the valve implant 10.

[0063] The valve implant 10 shown in FIG. 3f combines a single flap 20,as a valve mechanism 14, with an anchoring mechanism 12 that uses anexternal helical thread 34 to anchor the valve implant 10 to a valveleaflet 7. The helical thread 34 provides resistance to movement in boththe upstream and downstream directions. The helical thread 34 alsoprovides a self-tapping action when the valve implant 10 is beingscrewed into place in a leaflet 7.

[0064] One skilled in the art will realize that any of theaforementioned anchoring mechanisms 12 and valve mechanisms 14 may becombined in a single valve implant 10. For example, the valve implants10 shown in FIG. 2 include upstream and downstream posts 24 as well asupstream and downstream angled barbs 28.

[0065] A preferred embodiment of the valve implant 10 of the presentinvention is shown in FIGS. 4a and 4 b. The valve implant 10 isexpandable from the compressed configuration shown in FIG. 4a, to theexpanded configuration shown in FIG. 4b. The valve implant 10 isconstructed and arranged to fit within a catheter when in the compressedconfiguration. Compression may be accomplished radially, helically,longitudinally, or a combination thereof. Preferably, the compression ofthe valve implant 10 is radial.

[0066] Like the aforementioned embodiments of the valve implants 10, thevalve implant 10 of FIG. 4 generally includes an anchoring mechanism 12and a valve mechanism 14. The anchoring mechanism 12 generally comprisesa cuff 36 and a sizing ring 38. The cuff 36 is preferably constructed ofNitonol and has a middle portion 40 a set of radially expanding distallegs 42 and a set of radially expanding proximal legs 44.

[0067] In the compressed state, the legs 42 and 44 are somewhat alignedwith the middle portion 40 to allow the cuff 36 to be compressed into acatheter, preferably a 14 French catheter. The cuff 36 is eitherexpandable or self-expanding. Upon release from the catheter, the legs42 and 44 fold outwardly until they radiate from the middle portion 40at approximately right angles to the longitudinal axis of the cuff 36.The legs 42 and 44 are designed to act against the upstream anddownstream sides, respectively, of a valve leaflet, sandwiching theleaflet therebetween and anchoring the cuff 36 to the leaflet.

[0068] The anchoring mechanism 12 of the valve implant 10 shown in FIGS.4a and 4 b also includes a sizing ring 38. The sizing ring 38 ispreferably a stainless steel stent that circumjacently surrounds themiddle portion 40 of the cuff 36. The sizing ring 38 is constructed andarranged to expand with the cuff 36 until a predetermined size isreached. Once the predetermined size is reached, the sizing ring 38prevents further expansion by the cuff 36. Over expansion of the cuff 36could render the valve mechanism 14 inoperable, cause calcified tissueto break away from the stenosed valve and become released into the bloodstream, tear the leaflet tissue, or weaken the cuff 36.

[0069] The valve mechanism 14 includes a sleeve 46 and one or more valvemembers 48. The sleeve 46 may be rigid or flexible, but it is preferablyflexible. More preferably, the sleeve 46 is constructed of anysufficiently flexible material capable of withstanding the environmentto which it will be subjected, including but not limited to, anymammalian tissue, including human or pig tissue, vertebrate tissue, or apolymer or other synthetic material. The valve members 48 are shown asbeing duckbill valves but may be any of the aforementioned discussedvalve designs.

[0070] Most preferably, the valve mechanism 14 comprises an intactharvested valve from an animal, such as pig, and is taken from anappropriate location such that the expanded, original size is suitablefor use in the leaflets of the stenotic valve being treated. Theharvested valve is sutured or otherwise attached to the inside surfaceof the cuff 36. In operation, the valve implant 10 is compressed suchthat it can be placed in a small catheter for percutaneous delivery. Atthe time of delivery, the valve implant 10 is attached to a stenoticleaflet and radially expanded to its functional diameter. Prior to, orduring expansion, the distal and proximal legs 42 and 44 expandradially, allowing the cuff 36 to create a strong bulkhead-like fittingon both sides of the leaflet. After attachment is made to the leaflet,the cuff 36, sizing ring 38, and the valve mechanism 14 are radiallyexpanded to the functional diameter of the valve implant 10. During thisexpansion, the sizing ring 38 exhibits plastic deformation until itachieves the maximum diameter, at which point the sizing ring 38 resistsfurther expansion.

[0071]FIGS. 4c-4 f depict alternative configurations for the preferredvalve implant 10. The valve implant 10 in FIG. 4c has a sleeve 46attached to the anchoring mechanism 12 with two rows of sutures 166 andis configured so an upstream edge 168 of the sleeve 46 is roughlyaligned with the distal legs 42 of the anchoring mechanism 12. The valveimplant 10 in FIG. 4d has a sleeve 46 attached to the anchoringmechanism 12 with one row of sutures 166 and is configured so theupstream edge 168 of the sleeve 46 is roughly aligned with the proximallegs 44 of the anchoring mechanism 12. The valve implant 10 in FIG. 4ehas a sleeve 46 attached to the anchoring mechanism 12 with two rows ofsutures 166 and is configured so the downstream edge 170 of the sleeve46 is roughly aligned with the proximal legs 44 of the anchoringmechanism 12. The valve implant 10 in FIG. 4f has a sleeve 46 attachedto the anchoring mechanism 12 with one row of sutures 166 and isconfigured so the downstream edge 170 of the sleeve 46 is roughlyaligned with the distal legs 42 of the anchoring mechanism 12. Thesleeve 46 may comprise a scaffold to which valve members 48 areattached, or the entire valve mechanism 14 may be a harvested tissuevalve such as an aortic valve.

[0072] In one preferred embodiment, the valve implant 10 can beconfigured to include commissural support structure like a wireformstent as sometimes found in known standard sized prosthetic tissuevalves. In such a configuration, the valve material will comprise abiologic tissue such as human pericardium or equine pericardium or smallintestine submucousal tissue. In the present invention, the materialmust be thin enough to be compressed and perhaps folded so as to fit thevalve implant 10 within the delivery system (described below). In apreferred embodiment, such tissue has a thickness of around 180 micronsor less.

[0073] In another alternative embodiment, the cuff mechanism could be atorroidal shaped sack (not shown), similar in shape to a deflated innertube, attached to the exterior surface of the base of the valve implant10 and connected to a UV curable liquid polymer reservoir containedwithin the delivery catheter. The sack material is composed of anelastic material that can be radially expanded by a balloon angioplastycatheter or by the injection of the liquid polymer. The liquid adhesivecontained within the sack can be transformed to a solid polymer throughUV light activated cross-linking

[0074] This sack, essentially empty, can be manipulated by the deliverycatheter to straddle both sides or surfaces around the hole cut in theleaflet for receiving the valve implant 10. Once located, the sack canbe enlarged by an underlying balloon catheter. Then, UV curable liquidpolymer can be injected into the sack through the delivery catheter.Once filled with an adequate amount of a polymer and adjusteddistally/proximally to form sufficient bulges on both sides of the valveleaflet, a UV light emission source, located within the deliverycatheter near the bag is activated to wash the adhesive filled bag withUV curing light. Once hardened by the UV effect, the cuff maintains itsenlarged size without balloon support.

[0075] Referring to FIGS. 22A-24B, yet another embodiment of a valveimplant 10 of the present invention is shown, this embodiment being ahinged valve. In this embodiment, the valve implant 10 comprises a valve“poppet” 221 that is connected to a valve leaflet 7 by an attachmentmechanism 220 that operates much like a hinge. The valve poppet 221pivots between a sealed and an unsealed condition around the pivot pointof the attachment mechanism 220 according to the flow of blood (FIGS.24A and 24B).

[0076] The poppet 221 or “mini-leaflet” can be comprised of any materialsufficiently flexible to allow for the described movement yetsufficiently durable to withstand the environment. For example, thepoppet 221 may made from materials such as biologic tissue, a polymer ora carbon based material. Moreover, the poppet 221 could be coated withtissue prom the patient, e.g., tissue from a patient's vein wall. Thepoppet material may include supporting internal structure and/or anouter ring to ensure the structural integrity of the poppet 221 duringoperation. The poppet can have a curved in order to better conform thepoppet 221 to the contour of the native leaflet 7.

[0077] In this regard, after a hole is created in the leaflet 7(discussed below), the poppet 221 is pushed or screwed into the leaflet.It may be retained there by barbs or screw threads or by hooks or othertypes of retaining mechanisms.

[0078] The attachment mechanism 220 (FIGS. 22A-22B and 24A-24B), in apreferred embodiment, is a hinge. The hinge may fabricated from suchmaterials as a polymer strip, a biologic tissue strip, a metal (e.g.,stainless steel) strip or a pryolytic carbon material. Referring toFIGS. 24A and 24B, the hinged mechanism may be attached to the leaflet 7tissue using a barbed spike 240.

[0079] In an optional embodiment of the invention shown in FIGS.22A-24B, the valve implant 10 may also include a support ring 222 thatis disposed around the inside perimeter of the hole that is cut in theleaflet 7 to receive the valve implant 10. The support ring 222 mayserve to limit embolization and to enhance leaflet integrity (therebyavoiding prolapse). The support ring 222 could be deployed into the holeeither with an expanding balloon or it could be mechanically deployedusing a mechanical spreader.

[0080] Referring to FIGS. 23A-24B, the optional support ring 222 mayinclude struts 224, 225 that serve to capture the edges of the leaflet 7in the hole so as to support and retain the support ring 220 at thesite.

[0081] Catheter Delivery System

[0082] Referring now to FIGS. 5a and 5 b, there is shown a preferredembodiment of a catheter delivery system 50 of the present invention.The catheter delivery system 50 generally comprises a leaflet capturecatheter 52, a delivery catheter 54, a catheter sheath 56, and a handle58. The catheter delivery system 50 is preferably constructed andarranged for use with a guidewire 60.

[0083] As best seen in FIG. 6, the leaflet capture catheter 52 includesa cutter die 62 connected to a hemostatic hub 64 with a cannula 66. Thecutter die 62 may be of unitary construction and includes a conicaldistal end 68 that increases in radius proximally until a flat 70 isreached. Proceeding proximally, the flat 70 ends abruptly to form acapture groove 72. At the proximal end of the capture groove 72, thecutter die 62 returns to approximately the same diameter as the flat 70.The purpose of the cutter die 62 is to “grab” tissue that resiliently“pops” into the capture groove 72. Once in the capture groove 72, thetissue is held in place as a cutter 90 (explained below) cuts throughthe tissue.

[0084] One skilled in the art will realize that alternatives could beused instead of a cutter die 62. For example, the cutter die 62 could bereplaced with a balloon, constructed and arranged to be inflated on theupstream side of the leaflet 7 (or both sides of the leaflet to capturethe tissue) and sized to fit within the cutter 90. A second ballooncould also be arranged to be inflated on the downstream side of theleaflet, such that the leaflet is captured between the two balloons. Theballoon concept, though arguably more complicated and expensive, mayprove useful in situations where a cut needs to be made in tissue thathas lost the resiliency needed to “pop” into the capture groove 72 ofthe cutter die 62. Other devices, such as barbs and clamps, are alsoenvisioned to act in this manner.

[0085] The cannula 66 connects with the cutter die 62 and the hemostatichub 64. At the distal end of the cannula 66 is a needle tip 74. Theneedle tip 74 is angled to form a sharp point usable to puncture tissue.The cannula 66 includes a lumen 76 extending the length thereof. Thislumen 76 is used to accommodate a guidewire 60 (FIG. 5).

[0086] The hemostatic hub 64 allows the leaflet capture catheter 52 tobe removably attached to the handle 58. The hemostatic hub 64 includes abody 78, a threaded knob 80, and an elastomeric seal 82. The body 78defines an interior cavity 84 that is shaped to receive and hold acannula hub 86 that is attached to a proximal end of the cannula 66. Theinterior cavity 84 is also shaped to receive the elastomeric seal 82,which is compressed between the threaded knob 80 and the body 78. Theinterior cavity 84 is partially internally threaded to receive theexternal threads of the threaded knob 80. The threaded knob 80 defines aguidewire port 88 that aligns with the interior cavity 84 and the lumen76 of the cannula 66 so that a continuous port is available for theguidewire 60 to extend the length of the leaflet capture catheter 52.When a guidewire 60 is inserted through the guidewire port 88, thethreaded knob 80 and the elastomeric seal 82 act together as ahemostatic valve. When the threaded knob 80 is rotated to compress theelastomeric seal 82, the elastomeric seal 82 swells inwardly, until itforms a blood-tight seal around the guidewire 60. The cannula 66 and thehub 64 are constructed and arranged to carry the tensile force generatedduring a hole cutting procedure, discussed in detail below.

[0087] The leaflet capture catheter 52 is slidingly and coaxiallycontained within the delivery catheter 54. The delivery catheter 54 isbest shown in FIG. 7a, and includes a cutter 90, a balloon catheter 92,and a delivery catheter hub 94. The cutter 90 is constructed andarranged to act with the cutter die 62 (FIG. 6) to cut tissue. Thecutter 90 includes a cutter drum 96 that is a sharpened cylindricalblade having a cutting tip 98. The cutter tip 98, as shown in FIG. 7a,lies in a plane that is substantially perpendicular to a longitudinalaxis of the delivery catheter. However, an alternative embodiment of thecutter drum 96, shown in FIG. 7b, may provide increased cutting power.The cutter drum 96 in FIG. 7b has a curved, non-planar cutting tip 98.Preferably, the cutter drum 96 is sized to cut a hole having a diameterof approximately 4 mm through a leaflet. The cutter drum 96 has a cutterbulkhead 100 at its proximal end that is attached to the ballooncatheter 92 with an adhesive 102. Other suitable attachment means forattaching the cutter drum 96 to the balloon catheter 92 include threads,welds, unitary construction and the like. To cut tissue, the cutter die62 is pulled within the cutter drum 90. Thus, the balloon catheter 92,and the adhesive 102 fixing the bulkhead 100 to the balloon catheter 92,must be able to carry the compressive force that results from opposingthe equal and opposite tensile force applied to the leaflet capturecatheter 52.

[0088] The balloon catheter 92 generally includes an inner tube 104extending distally and proximally from within an outer tube 106. Aballoon 108 is connected at a distal end to the outside of the innertube 104 and at a proximal end to the outside of the outer tube 106. Theoutside diameter of the inner tube 104 is smaller than the insidediameter of the outer tube 106, such that a fluid passageway is formedtherebetween for inflation of the balloon 108. A flexible valve stop 110is attached to the outer tube 106 just proximal of the proximal end ofthe balloon 108. The valve stop 110 has a flexible sleeve 112 thatextends distally over the proximal end of the balloon 108. The functionof the valve stop 110 is to prevent proximal movement of the valveimplant 10 during delivery. The valve implant 10, as will be seen below,will be placed over the balloon 108, distal of the valve stop 110. Theflexible sleeve 112 allows the balloon to inflate while maintaining adesired positioning of the valve implant 10. The inner tube 104 has aninner diameter large enough to accommodate the cannula 66 of the leafletcapture catheter 52. A proximal end of the balloon catheter 92 isattached to the catheter hub 94.

[0089] The catheter hub 94 includes a catheter hub body 114 that definesan inner cavity 116 and a balloon inflation port 118. The proximal endof the inner cavity 116 has internal threads to receive an externallythreaded knob 120. An elastomeric seal 122 resides between the threadedknob 120 and the catheter hub body 114. The threaded knob 120 defines acapture catheter port 124 that aligns with the interior cavity 116 ofthe body 114 and the interior of the balloon catheter 92 so that theleaflet capture catheter 52 may pass therethrough.

[0090] The balloon catheter 92 is attached to the catheter hub 94 insuch a manner that fluid introduced into the balloon inflation port 118will flow between the outer tube 106 and the inner tube 104 to inflatethe balloon 108. The outer tube 106 is attached at its proximal end tothe distal end of the interior cavity 116 of the catheter hub body 114.Preferably, an adhesive 126 is used to connect the outer tube 106 to theinterior cavity 116 of the catheter hub body 114 at a position distal ofthe balloon inflation port 118. The inner tube 104 extends proximallyfrom the proximal end of the outer tube 108. The proximal end of theinner tube 104 is also attached to the interior cavity 116 of thecatheter hub body 114. However, this connection is made at a positionproximal of the balloon inflation port 118, preferably with an adhesive128. Thus, fluid entering the balloon inflation port 118 is blocked fromflowing in a proximal direction by the proximal adhesive 128. It is alsoblocked from traveling in a distal direction on the outside of outertube 106 by the distal adhesive 126. Instead, the fluid is forced toflow between the inner tube 104 and the outer tube 106 in a distaldirection toward the interior of the balloon 108.

[0091] The leaflet capture catheter 52 and the delivery catheter 54 areslideably contained within the sheath catheter 56. Referring now to FIG.8, it can be seen that the sheath catheter 56 includes a large diametersheath 130 attached to a distal end of sheath tubing 132, which isattached at a proximal end to a sheath hub 134. The sheath hub 134secures the sheath catheter 56 to the handle 58. The sheath hub 134includes a tab 154, the function of which will be explained below. Thesheath 130, sheath tubing 132, and the sheath hub 134, all define adelivery catheter port 136 that extends throughout the length of thesheath catheter 56. The large diameter sheath 130, is preferably a 14French catheter, and sized to accommodate the cutter drum 96.

[0092] Referring now to FIGS. 9A and 9B, there is shown a preferredembodiment of the handle 58 of the present invention. The handle 58includes a handle body 138 that defines at a bottom portion a figuregrip 140. An actuator 142 is pivotally attached to the handle body 138with a pivot pin 164. At the top of the actuator 142, is a leafletcapture catheter bracket 144. The leaflet capture catheter bracket 144is constructed and arranged to hold the leaflet capture hemostatic hub64. At a top portion of the body 138 there is defined a slotted chamber146. The slotted chamber 146 is constructed and arranged to hold thedelivery catheter hub 94 as well as the sheath hub 134. The slottedchamber 146 includes external threads 148 around which the sheathretraction nut 150 rides. At the top of the slotted chamber 146 there isdefined a slot 152 through which the balloon inflation port 118 of thedelivery catheter hub 94 and a tab 154 of the sheath hub 134 extend.Below the slotted chamber 146, a sheath retraction indicator 156 extendsdistally from the handle body 138. Preferably, the handle 58 includes asafety button 158 that prevents a physician from unintentionallydepressing the actuator 142.

[0093] The handle 58 is thus constructed and arranged to slide theleaflet capture catheter 52 in a proximal direction relative to thesheath catheter 56 and the delivery catheter 54 when the actuator 142 issqueezed toward the finger grip 140, thereby pulling the hemostatic hub64 in a proximal direction. The handle 58 is also constructed andarranged to slide the sheath catheter 56 proximally over the leafletcapture catheter 52 and the delivery catheter 54 when the sheathretraction nut 150 is rotated proximally. The operation of the handle 58and the rest of the delivery system 50 are explained in more detailbelow.

[0094] Referring to FIGS. 19A, 19B and 20, in one embodiment of thepresent invention, the catheter delivery system 50 includes a tether 190looped around the proximal legs 44 of the valve implant 10. The tetherextends from the proximal legs 44 all the way through the catheter untilboth ends of the tether 190 are joined at a connector 192 that residesoutside the catheter delivery system 50 near the handle. The tether 190allows the user to retract the valve implant 10 from the valve placementsite after it has been deployed from the catheter If It is determinedthat the deployment was improper or in the event a complication ariseswith after deployment.

[0095] For example, if after deployment, it is determined that placementof the valve implant 10 is incorrect, the physician can pull on thetether and retract the valve implant 10 as shown in FIG. 19B. If, on theother hand, it is determined that placement of the valve implant 10 hasbeen successful, then the physician simply cuts the tether and pulls thefree end out of from the proximal legs 44 and out of the delivery deviceas shown in FIG. 1 9A.

[0096] Operation

[0097] Referring now to FIGS. 10-19, the operation of the presentinvention is explained. Each of the following figures will include twodrawings, a drawing that shows the position of the handle 58, and adrawing of the corresponding catheter configuration.

[0098] Referring now to FIG. 10, the first step a physician takes inusing the delivery device 50 to place a valve implant 10 in a leaflet ofa native valve is to use a guidewire 60 to locate the site of the nativevalve. The guidewire 60 is thus threaded through the necessary bloodvessels to the site of the native valve. For example, if it were desiredto place the valve implant 10 in, or between, the leaflets of the aorticvalve, the guidewire 60 would be placed percutaneously in the femoralartery, or other suitable arterial access, advanced up the aorta, aroundthe arch, and placed above the target leaflet of the aortic valve. Oncethe guidewire 60 is in place, the catheter delivery system 50 isadvanced along the guidewire 60.

[0099] In FIG. 10a, it can be seen that the target leaflet 7 has beenlocated with the guidewire 60 and the catheter delivery system 50 hasbeen advanced along the guidewire 60 the target leaflet 7. Positioningthe catheter delivery system 50 on the target leaflet 7 may be aidedusing imaging methods such as fluoroscopy and/or ultrasound. FIG. 10ashows that when this step is performed, the sheath retraction nut 150 isin the “Deliver” position as shown on the sheath retraction indicator156. In the “Deliver” position, the sheath 130 covers the capture groove72 of the cutter die 62. The cutter 90 remains retracted proximal of thecapture groove 72. Also, the conical distal end 68 of the cutter die 62extends from the distal end of the sheath 130.

[0100] In this regard, it is helpful to note that the target leaflet mayactually include two leaflets if the leaflets are calcified together.For example, with reference to FIG. 1, if two leaflets have becomecalcified together along their edges or lines of coaptation, the presentinvention contemplates cutting a hole in a manner that traverses theleaflet edges and thereafter inserting a valve (as explained below)across both leaflet edges.

[0101] Once satisfied that the target site has been reached with thecatheter delivery system 50, the next step is to traverse the tissue ofthe target valve leaflet 7. However, before the cutter die 62 isadvanced through the leaflet tissue 7, the sheath catheter 56 must beretracted until the “Insert/Cut” position has been achieved. This isaccomplished by rotating the threaded sheath retraction nut 150 untilthe nut 150 is aligned with the “Insert/Cut” marking on the sheathretraction indicator 156. Rotating the sheath retraction nut 150 causesthe nut 150 to act against the tab 154 of the sheath hub 134.

[0102] Referring now to FIGS. 11a and 11 b, it can been seen that thetarget valve leaflet 7 has been punctured by either the guidewire 60, inthe event that a sufficiently sharp guidewire is being used, or morepreferably, the needle tip 74 of the leaflet capture catheter 52. Whenthe needle tip 74 of the leaflet capture catheter 52 is used to puncturethe leaflet, the guidewire 60 is first retracted so that it does notextend through the needle tip 74.

[0103] In one embodiment, the needle may be configured to have a hollowsharp shaft followed by a conical shank (not shown). This will allow theneedle to create an initial penetration of the tissue followed by a moretraditional puncturing action from the conical shank A needle configuredin this manner will also assist in positioning the delivery device overeach leaflet.

[0104] The cutter die 62 is advanced through the leaflet 7 until theleaflet 7 snaps into the capture groove 72. The conical distal end 68,as it is being advanced through the leaflet 7, will provide anincreasing resistance that is tactily perceptible to the physician. Oncethe leaflet 7 encounters the flat portion 70, the physician will detecta decreased resistance and can expect a snap when the resilient tissuesnaps into the capture groove 72. The guidewire 60 is then re-advancedinto the ventricle (assuming the aortic valve is the target valve).

[0105] In this regard, it is notable that in one embodiment of theinvention, the guidewire could be fabricated to include a transducer atits distal end (not shown). The guidewire could then be used to measureventricular pressure (e.g., left ventricular pressure when treating theaortic valve) and thus provide the physician greater ability to monitorthe patient during the procedure.

[0106] Once the physician is convinced that the leaflet 7 has enteredthe capture groove 72, the cutting step may commence. Referring now toFIGS. 12a and 12 b, the cutting step is demonstrated. Cutting isperformed by depressing safety button 158 and squeezing the actuator142. After the safety button 158 and the actuator 142 are squeezed, thespring loaded safety button on 158 will travel from a first hole 160 inthe actuator 142 to a second hole 162. When the safety button 158reaches the second hole 162, it will snap into the second hole 162,thereby locking the actuator 142 in place. This ensures that the cutterdie is retracted into the cutter 90, but that excess pressure is notplaced on either the cutter die 62 or the cutter 90. When the actuator142 is squeezed, cutting is effected because the actuator 142 rotates,relative to the handle body 138, around the pivot pin 164. This actioncauses the leaflet capture catheter bracket 144 to move in a proximaldirection thereby pulling the hemostatic hub 64 with it. Pulling the hub64 causes the cannula 66 and the cutter die 62 attached thereto, to bepulled in a proximal direction relative to the delivery catheter 64. Thecutter die 62 enters the cutter 90, thereby cutting the tissue. Theclearance between the cutter die 62 and the cutter drum 96 issufficiently minimal to prevent the occurrence of hanging “chads” in thecut. Additionally, the sharpened cutting tip 98 of the cutter 90 may becut at an angle, or even include a point, such that the entire cut doesnot have to be initiated around the entire circumference of the cutterdrum 96 simultaneously.

[0107] A more detailed view of the cutting action of the cutter die 62and the cutter 90 is shown in FIGS. 13a-13 e. In FIG. 13a, the needletip 74 of the cannula 66 has just reached the leaflet 7. The sheath 130has been retracted to the “Insert/Cut” position as indicated by theexposed capture groove 72 of the cutter die 62. In FIG. 13b, the cutterdie 62 is being advanced through the target leaflet 7 such that thetarget leaflet 7 has reached the conical distal end 68 of the cutter die62. In FIG. 13c, the conical distal end 68 and the flat portion 70 ofthe cutter die 62 have passed completely through the target leaflet 7,and the target leaflet 7 has snapped into the capture groove 72.Additionally, the guidewire 60 has been re-advanced through the leafletcapture catheter 52 so that it extends beyond the needle tip 74. Theguidewire 60 will be used to retain the position of the hole cut throughthe leaflet 7 after the cutter die 62 is retracted. In FIG. 13d, thephysician has begun to cut by squeezing the actuator 142 (FIG. 12a), asevidenced by the advancement of the cutter 90. The cutting tip 98 of thecutter 90 has been advanced mid-way through the target leaflet 7. Thismovement is relative to the position of the cutter die 62. Moreaccurately, the cutter die 62 is being retracted into the cutter 90,bringing with it the tissue of the leaflet 7. The movement of the cutterdie 62 is evidenced by arrow 172.

[0108] In FIG. 13e, the cut is complete as the actuator 142 has beensqueezed enough so that the safety button 158 has found the second hole162 (FIG. 12a), as evidenced by the position of the cutter die 62. Thecutter die 62 is retracted enough such that the capture groove 72 iscompletely housed within the cutter drum 96. Notably, the cut tissue ofthe leaflet 7 remains trapped between the capture groove 72 and thecutter drum 96. The trapping of this tissue prevents the tissue fromtraveling downstream through the blood vessel and causing damage.

[0109] Referring now to FIGS. 14a and 14 b, once the hole in the tissue7 is cut, the step of placing the valve implant 10 begins. First, theentire delivery system 50 is moved distally deeper into the patient suchthat the distal legs 42 pass through the newly formed hole in the tissue7. It is important that at least the distal legs 42 are located on theupstream (ventricle) side of the tissue 7 prior to deploying the valveimplant 10 Once the physician is confident that the distal legs 42extend beyond the valve leaflet tissue 7, the sheath 130 may beretracted to release the distal legs 42. This is accomplished byrotating the sheath retraction nut 150 until the sheath retraction nut150 aligns with the “Distal” marking on the sheath retraction indicator156. Doing so causes the sheath retraction nut 150 to act against thetab 154 thereby withdrawing the sheath 130 until just the distal legs 42are exposed. The distal legs 42 are preloaded such that they springoutwardly, as shown in FIG. 14b, when uncovered by the catheter sheath130. The distal legs 42 are long enough to extend beyond the radius ofthe sheath 130, such that they may act against the valve leaflet tissue7. Once the sheath retraction nut 150 has been rotated to the “Distal”position on the indicator 156, the physician may pull the catheterdelivery system 50 in a proximal direction until he or she feels thedistal legs 42 catch or act against the valve leaflet tissue 7. Notably,the actuator 142 remains locked in the position it was placed in duringthe cutting procedure. Leaving the actuator 142 in this position ensuresthat the valve leaflet tissue trapped between the cutter die 62 and thecutter drum 96 is not released.

[0110] The next step is illustrated in FIGS. 15a and 15 b. The physicianmaintains the contact between the distal legs 42 and the valve leaflettissue 7. While maintaining this contact, the sheath retraction nut 150is rotated to the “Proximal” position as indicated on the marker of thesheath retraction indicator 156. Rotating the sheath retraction nut 150again acts against the tab 154 causing the sheath 130 to retractfurther. When the proximal position has been achieved, the sheath willbe retracted enough to release the proximal legs 44. Like the distallegs 42, the proximal legs 44 will spring outwardly when released by thesheath 130. The proximal legs 44 act against the opposite side (aortaside) of the valve leaflet tissue 7 sandwiching the valve leaflet tissue7 between the distal legs 42 and the proximal legs 44. The valve implant10 is now attached to the patient.

[0111] The next step is to inflate the balloon 108 thereby expanding thevalve implant 10. This step is best shown in FIGS. 16a and 16 b. Thephysician further rotates the sheath retraction nut 150 to the “Inflate”position on the indicator 156. The sheath retraction nut 150 again actsagainst the tab 154 thereby retracting the sheath 130 to a point wherethe valve stop 110 is at least partially exposed and the flexible sleeve112 of the valve stop 110 is completely exposed.

[0112] Once the sheath 130 has been retracted to the “Inflate” positionon the indicator 156, the balloon 108 may be inflated. This isaccomplished by injecting fluid into the balloon inflation port 118.Fluid is injected until the sizing ring 38 has achieved its maximumdiameter. The physician will feel resistance against further inflationby the sizing ring 38. Additionally, the sizing ring 38 or other partsof the anchoring mechanism 12 may be constructed of a radiopaquematerial such that monitoring can be accomplished using X-ray equipment.The use of the sizing ring 38 is not required for the practice of theinvention. It is, however, preferred in the preferred embodiments of theinvention.

[0113] Once the inflation of the balloon 108 is complete, the next stepinvolves deflating the balloon 108. This is illustrated in FIGS. 17a and17 b. Deflating the balloon involves simply withdrawing fluid throughthe balloon inflation port 118. As is shown in FIG. 17b, when theballoon 108 is deflated, the valve implant 10 retains its inflatedproportions. These inflated proportions allow easy retraction of thecatheter delivery system through the valve implant 10. As is best seenin FIG. 18, once the delivery system 50 has been retracted, the valveimplant 10 remains attached to the valve leaflet tissue 7.

[0114] As discussed above with reference to FIGS. 19A, 19B and 20, oneembodiment of the catheter delivery device 50 and the valve implant 10includes the use of a tether 190 to allow the physician to retract thevalve implant 10 in the event of improper deployment. With reference toFIG. 21, the operation of the tether 190 under both proper deploymentand improper deployment is disclosed.

[0115] On the left side of FIG. 21, it is seen that the valve implant 10has been properly deployed in the valve leaflet. As a result, thephysician cuts the tether 190 and pulls the tether away from thecatheter handle from the proximal legs 44 of the cuff.

[0116] On the right side of FIG. 22, it is seen that the valve implant10 has been improperly deployed insofar as the legs of the cuff have notadequately grasped the edge of the hole in the leaflet. As a result, thephysician may retract the valve implant 10 by pulling on the tether 190and thus removing the valve implant 10 from its improperly deployedlocation

What is claimed is:
 1. A method of increasing fluid flow through a bloodvessel valve comprising creating an opening through at least one leafletof the valve through which fluid may flow.
 2. The method of claim 1further comprising placing a valve implant in operational proximity tothe opening, the valve implant having a mechanism capable of allowingflow through the implant in a desired direction and blocking flowthrough the implant in an opposite direction.
 3. The method of claim 2wherein placing a valve implant in operational proximity to the openingcomprises percutaneously placing a valve implant in operationalproximity to the opening.
 4. The method of claim 3 whereinpercutaneously placing a valve implant in operational proximity to theopening comprises urging the valve implant through at least one leafletof the valve, thereby creating the opening, and placing the valveimplant in operational proximity to the opening, simultaneously.
 5. Themethod of claim 3 wherein percutaneously placing a valve implant inoperational proximity to the opening comprises screwing the valveimplant into at least one leaflet of the valve thereby creating theopening, and placing the valve implant in operational proximity to theopening, simultaneously.
 6. The method of claim 3 wherein percutaneouslyplacing a valve implant in operational proximity to the openingcomprises cutting a hole through at least one leaflet of the valve andthen placing the valve implant into the hole and attaching the at leastone valve implant to the at least one leaflet.
 7. The method of claim 6further comprising expanding the hole after attaching the valve implantto the at least one leaflet.
 8. The method of claim 7 wherein expandingthe valve implant comprises inflating a balloon inside the valve implantuntil the hole expands to a predetermined diameter.
 9. The method ofclaim 3 wherein percutaneously placing a valve implant in operationalproximity to the opening comprises cutting a hole through at least oneleaflet of the valve and then placing the valve implant over the holeand attaching the valve implant to the at least one leaflet.
 10. Amethod of treating a diseased valve comprising: diagnosing a diseasedstate of a valve in a patient; delivering a prosthetic valve to saiddiseased valve; deploying said prosthetic valve in native tissue of saiddiseased valve; and securing said prosthetic valve in said tissue.
 11. Amethod according to claim 10, wherein the deploying of said prostheticvalve includes deploying the prosthetic valve in a leaflet of saiddiseased valve.
 12. A method according to claim 10, wherein thedeploying of said prosthetic valve includes deploying the prostheticvalve across a plurality of leaflets of said diseased valve.
 13. Amethod according to claim 10, wherein the delivering of the prostheticvalve is performed percutaneously.
 14. A method according to claim 10,wherein the prosthetic valve is in a compressed stated during thedelivering of said prosthetic valve to said diseased valve.
 15. A methodaccording to claim 10, including placing a second prosthetic valve insaid native tissue following the securing of said prosthetic valve insaid tissue.
 16. A method of improving fluid flow through a diseasedvalve in a body lumen comprising: determining that a flow through saiddiseased valve is deficient; excising a portion of valve tissuetraversing said lumen; improving flow through said diseased valve byinserting an implant where said portion of said valve tissue has beenexcised.
 17. A method according to claim 16, wherein the improving offlow comprises inserting a valve implant.
 18. A method according toclaim 16, wherein the excising and the improving is performedpercutaneously.
 19. A method according to claim 16, wherein the excisingincludes excising a portion of a leaflet of said valve.
 20. A methodaccording to claim 16, wherein the excising and improving is performed asecond time for a second implant.